Comparison of the Safety and Cost of a Simplified Post-Operative Radiograph (SPOR) Protocol

NCT ID: NCT04110470

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2024-05-01

Brief Summary

The standard post-operative radiographic protocol for the monitoring of fractures at Health Sciences Centre includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.

Conditions

Fractures, Bone; Fracture Complications; Xray Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks.

Group Type: ACTIVE_COMPARATOR

X-ray

Intervention Type: DIAGNOSTIC_TEST

Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks.

Treatment Group

These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.

Group Type: EXPERIMENTAL

No-Xray

Intervention Type: DIAGNOSTIC_TEST

These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.

Interventions

X-ray

Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks.

Intervention Type: DIAGNOSTIC_TEST

No-Xray

These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• At least one lag screw for each fracture line
• At least one compression plate across each fracture line
• Locked intramedullary nail
• Articular/peri-articular fracture with antiglide/under-contoured plate
• Tension band technique (plate included) in simple fracture pattern
• Operating surgeon is confident in fixation construct, despite non-load sharing criteria.

Exclusion Criteria

• Fracture >21 days old
• Age <18 years, or open growth plates
• Articular fracture with depression
• Multiple orthopaedic fractures
• History or radiographic appearance of osteoporosis/osteopenia or poor operative bone quality
• Likely difficulty with follow-up in first 6 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tudor V Tufescu, BSc, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Central Contacts

Nigar Sultana

Role: CONTACT

nsultana@hsc.mb.ca

(204) 787-8691

Other Identifiers

HS22019 (B2018:067)

Identifier Type: -

Identifier Source: org_study_id